GET TESTED INTERNATIONAL AB recalled one unit of its Drug Test Small on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. The FDA classified this recall as Class II, indicating a high risk to patients and healthcare providers.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Drug Test Small (4 substances) with EAN: 7340221701045 and SKU: A-DR4. It is distributed nationwide in the US. The recall involves all lots of the product.
The product was distributed without the necessary premarket approval or clearance. This raises serious concerns about its safety and efficacy for drug testing.
No specific incidents or injuries have been reported related to this recall. However, the classification as Class II indicates potential risks.
Patients and healthcare providers must stop using the drug test immediately. For further instructions, contact GET TESTED INTERNATIONAL AB or your healthcare provider.
For more information, visit the FDA recall report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0734-2026.
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